Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

Shanghai Henlius Biotech / Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/shanghai-henlius-biotech-inc" target="_blank" data-smartkarma-citation="entities:27888:1" rel="noopener">Shanghai Henlius Biotech (2696 HK)</a> granted Eisai license to develop, manufacture and commercialize Hansizhuang (serplulimab injection) in the treatment of oncology indications in Japan.</li>
<li>Hansizhuang is an innovative anti-PD-1 monoclonal antibody approved for marketing in China for indications including the combination with chemotherapy for the first-line treatment of sq &amp; nsq-NSCLC, ES-SCLC and ESCC.</li>
<li>The recurrent licensing agreement, the increasing contribution of in-house innovative drug coupled with consistent indication and geographic expansion will help build a sustainable revenue flow.</li>
</ul>



Shanghai Henlius Biotech (2696 HK) granted Eisai license to develop, manufacture and commercialize Hansizhuang (serplulimab injection) in the treatment of oncology indications in Japan.
Hansizhuang is an innovative anti-PD-1 monoclonal antibody approved for marketing in China for indications including the combination with chemotherapy for the first-line treatment of sq &amp; nsq-NSCLC, ES-SCLC and ESCC.
The recurrent licensing agreement, the increasing contribution of in-house innovative drug coupled with consistent indication and geographic expansion will help build a sustainable revenue flow.


Shanghai Henlius (2696 HK): Licensing Agreement With Eisai for Hansizhuang Yet Another Milestone

Thematic (Sector/Industry)

<ul>
<li>Henlius Biotech is collaborating with Sandoz for commercialization of up to 10 biosimilars in ~$322M deal. Wuxi XDC achieved GMP release of its antibody bioconjugates production line at Singapore site.</li>
<li>Chugai Pharmaceutical signed an exclusive license agreement with GSK for the anti-dengue virus antibody AID351. Daiichi Sankyo’s Enhertu demonstrated PFS improvement as first-line treatment of NSCLC in Phase 3 trial.</li>
<li>Celltrion has launched IV formulation of Steqeyma in Japan. Eubiologics submitted an IND to the MFDS for domestic Phase 1 trial for its Alzheimer’s disease vaccine candidate, Padivax.</li>
</ul>


Henlius Biotech is collaborating with Sandoz for commercialization of up to 10 biosimilars in ~$322M deal. Wuxi XDC achieved GMP release of its antibody bioconjugates production line at Singapore site.
Chugai Pharmaceutical signed an exclusive license agreement with GSK for the anti-dengue virus antibody AID351. Daiichi Sankyo’s Enhertu demonstrated PFS improvement as first-line treatment of NSCLC in Phase 3 trial.
Celltrion has launched IV formulation of Steqeyma in Japan. Eubiologics submitted an IND to the MFDS for domestic Phase 1 trial for its Alzheimer’s disease vaccine candidate, Padivax.


APAC Healthcare Weekly (August 23) – Henlius Bio, Wuxi XDC, Chugai Pharma, Daiichi Sankyo, Celltrion

<ul>
<li>Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).</li>
<li>InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.</li>
<li>Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.</li>
</ul>


Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).
InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.
Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.


APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

<ul>
<li>Sino Biopharmaceutical entered outlicensing deal with AstraZeneca for respiratory drug candidate TQC3721. Hansoh Pharmaceutical’s ADC drug candidate HS-20093 met primary endpoint of overall survival in Phase 3 trial for SCLC.</li>
<li>Wuxi Biologics’ Hebei drug substance manufacturing facility passed the Pre-License Inspection by the FDA. Astellas Pharma’s Padcev Keytruda combo was accepted for China review in perioperative muscle-invasive bladder cancer.</li>
<li>Otsuka’s Astex Pharmaceuticals inked R&amp;D deal with Genentech to identify small molecule breast cancer drug candidates. Celltrion’s Avastin biosimilar has secured formulary listings with two major PBMs in the U.S.</li>
</ul>


Sino Biopharmaceutical entered outlicensing deal with AstraZeneca for respiratory drug candidate TQC3721. Hansoh Pharmaceutical’s ADC drug candidate HS-20093 met primary endpoint of overall survival in Phase 3 trial for SCLC.
Wuxi Biologics’ Hebei drug substance manufacturing facility passed the Pre-License Inspection by the FDA. Astellas Pharma’s Padcev Keytruda combo was accepted for China review in perioperative muscle-invasive bladder cancer.
Otsuka’s Astex Pharmaceuticals inked R&amp;D deal with Genentech to identify small molecule breast cancer drug candidates. Celltrion’s Avastin biosimilar has secured formulary listings with two major PBMs in the U.S.


APAC Healthcare Weekly (July 12) – Sino Bio, Hansoh Pharma, Wuxi Bio, Astellas, Otsuka, Celltrion

<ul>
<li>InSilico Medicine and SK Biopharmaceuticals entered R&amp;D collaboration to discover AI-enabled neuroimmune drug candidates. Abbisko Cayman entered into a strategic research collaboration and license agreement with Eli Lilly.</li>
<li>Nippon Shinyaku’s partner Regenxbio cleared path to resubmit Hunter syndrome gene therapy candidate RGX-121 to the FDA. Otsuka announced positive topline results in Phase 3b study evaluating centanafadine in ADHD.</li>
<li>Yuhan Corp received orphan drug designation from the EMA for its Gaucher disease therapy candidate YH35995. Medytox obtained approval for its hyaluronic acid filler Neuramis Deep Lidocaine in China.</li>
</ul>


InSilico Medicine and SK Biopharmaceuticals entered R&amp;D collaboration to discover AI-enabled neuroimmune drug candidates. Abbisko Cayman entered into a strategic research collaboration and license agreement with Eli Lilly.
Nippon Shinyaku’s partner Regenxbio cleared path to resubmit Hunter syndrome gene therapy candidate RGX-121 to the FDA. Otsuka announced positive topline results in Phase 3b study evaluating centanafadine in ADHD.
Yuhan Corp received orphan drug designation from the EMA for its Gaucher disease therapy candidate YH35995. Medytox obtained approval for its hyaluronic acid filler Neuramis Deep Lidocaine in China.


APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

China

Shanghai Henlius Biotech is a global, innovation-driven biopharmaceutical company focused on delivering high-quality, affordable biologic therapies for oncology, autoimmune diseases, and ophthalmic diseases. The company is engaged in biopharmaceutical research and development, manufacturing, and commercialization, offering products such as the biosimilars HANLIKANG (rituximab), HANQUYOU (trastuzumab), HANDAYUAN (adalimumab), and HANBEITAI (bevacizumab), as well as the innovative biologic HANSIZHUANG (serplulimab). Headquartered in Shanghai, China, the company was founded in 2010.

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Shanghai Henlius Biotech (2696 HK)

Shanghai Henlius (2696 HK): Licensing Agreement With Eisai for Hansizhuang Yet Another Milestone

Shanghai Henlius Biotech grants Eisai license for Hansizhuang in Japan for oncology treatment, expanding revenue opportunities with innovative...

Tina Banerjee

APAC Healthcare Weekly (August 23) – Henlius Bio, Wuxi XDC, Chugai Pharma, Daiichi Sankyo, Celltrion

Henlius strikes biosimilar commercialization deal with Sandoz. Chugai signs exclusive license deal with GSK for anti-dengue virus antibody....

Tina Banerjee

APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

Kelun Biotech’s sac-TMT met primary endpoint in Phase 3 trial. FDA approves Eisai’s Leqembi Iqlik for Alzheimer’s starting therapy. Mesoblast met...

Tina Banerjee

APAC Healthcare Weekly (July 12) – Sino Bio, Hansoh Pharma, Wuxi Bio, Astellas, Otsuka, Celltrion

Sino Bio stuck outlicensing deal with AstraZeneca. Hansoh’s ADC drug candidate met primary endpoint in Phase 3 trial. China will review Astellas’...

Tina Banerjee

APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

Few Chinese companies signed outlicensing deals. Nippon Shinyaku’s partner Regenxbio will resubmit gene therapy drug candidate to FDA. Otsuka...

Tina Banerjee

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Shanghai Henlius (2696 HK): Licensing Agreement With Eisai for Hansizhuang Yet Another Milestone

​Shanghai Henlius Biotech grants Eisai license for Hansizhuang in Japan for oncology treatment, expanding revenue opportunities with innovative...

Tina Banerjee

APAC Healthcare Weekly (August 23) – Henlius Bio, Wuxi XDC, Chugai Pharma, Daiichi Sankyo, Celltrion

Henlius strikes biosimilar commercialization deal with Sandoz. Chugai signs exclusive license deal with GSK for anti-dengue virus antibody....

Tina Banerjee

APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

Kelun Biotech’s sac-TMT met primary endpoint in Phase 3 trial. FDA approves Eisai’s Leqembi Iqlik for Alzheimer’s starting therapy. Mesoblast met...

Tina Banerjee

APAC Healthcare Weekly (July 12) – Sino Bio, Hansoh Pharma, Wuxi Bio, Astellas, Otsuka, Celltrion

Sino Bio stuck outlicensing deal with AstraZeneca. Hansoh’s ADC drug candidate met primary endpoint in Phase 3 trial. China will review Astellas’...

Tina Banerjee

APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

Few Chinese companies signed outlicensing deals. Nippon Shinyaku’s partner Regenxbio will resubmit gene therapy drug candidate to FDA. Otsuka...

Tina Banerjee

Shanghai Henlius Biotech grants Eisai license for Hansizhuang in Japan for oncology treatment, expanding revenue opportunities with innovative...